Incidence of Venous Thromboembolism Following Surgery in Patients With Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Keun-Wook Lee, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01345773
First received: April 29, 2011
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

Venous thromboembolism (VTE) has considerably harmful effects on morbidity and mortality of cancer patients. Several guidelines recommendations have been made about the use of anticoagulation for the prevention and treatment of VTE in Western patients with cancer. In Western VTE guidelines, all solid cancer patients receiving abdominal major surgery are strongly recommended to receive pharmacologic prophylactic anticoagulation such as low molecular weight heparin (LMWH) in the perioperative periods. These guideline recommendations are based on high incidence of postoperative VTE development in Western cancer patients. However, there have been many cumulative data about the effect of different ethnicity on the VTE development and more and more investigators and clinicians admit that Asian ethnicity has lower incidence of VTE than Western ethnicity. Therefore, it may not be advisable to apply Western guidelines as it is to the clinical situation of Asian cancer patients.

Although gastric cancer is the common cancer in Asia, there is no prospective data on the incidence of VTE development during the postoperative period of gastric cancer surgery. In other words, Asian doctors including Korean clinicians don't know the exact incidence of surgery-related VTE. From their clinical experiences, most Korean surgeons think that the incidence of postoperative VTE development is rare. They also have much concern about the complications such as bleeding that might be caused by routine use of pharmacologic thromboprophylaxis during the perioperative periods. Therefore, in most clinical situation, Korean surgeons do not perform perioperative pharmacologic thromboprophylaxis using LMHW. Considering these clinical situations in Korea, the uncritical acceptance of Western guidelines is inappropriate. The necessity of pharmacologic thrombo-prophylaxis can be answered only from the results of the prospective study on the incidence of postoperative VTE development after gastric cancer surgery. Moreover, current surgical trend in cancer patients is minimally invasive approach such as laparoscopic surgery. However, the necessity of pharmacologic thromboprophylaxis in patients receiving laparoscopic cancer surgery has not been evaluated even in Western countries. Western guidelines also cannot exactly answer whether pharmacologic thromboprophylaxis is really necessary in cancer patients receiving laparoscopic cancer surgery. On above backgrounds, this study was designed.


Condition Intervention
Gastric Cancer
Venous Thromboembolism
Postoperative Period
Procedure: Gastric surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Venous Thromboembolism Following Surgery in Patients With Gastric Cancer; a Prospective Study

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • The incidence of symptomatic or asymptomatic VTE [ Time Frame: 5~12 days after the gastric cancer surgery (by doppler US) or the follow-up period of postoperative 1 month ] [ Designated as safety issue: No ]
    To evaluate the incidence of symptomatic or asymptomatic VTE detected by Doppler venous ultrasound during postoperative periods in patients with gastric cancer receiving surgery


Secondary Outcome Measures:
  • Risk factors for the development of VTE [ Time Frame: 5~12 days after the gastric cancer surgery (by doppler US) or the follow-up period of postoperative 1 month ] [ Designated as safety issue: No ]
    To identify risk factors for the development of VTE in this population


Enrollment: 375
Study Start Date: May 2010
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients receiving gastric cancer surgery Procedure: Gastric surgery
Patients receiving gastric cancer surgery will be prospectively observed for the development of venous thromboembolism

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with gastric cancer receiving curative or palliative gastric cancer surgery

Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of stomach or gastroesophageal junction
  • Age ≥ 20 years
  • Patients receiving curative or palliative abdominal surgery (lasting ≥ 30 minutes) (both open and laparoscopic surgery will be included)

Exclusion Criteria:

  • No histological confirmation
  • Patients who already have VTE (or pulmonary embolism) at the screening periods of this study
  • Past medical history of VTE or pulmonary embolism
  • Patients with the history of other cancer (Patients who were disease-free for > 5 years from previous other cancer is allowed to be included in this study)
  • Patients with thrombophilia or other comorbidities requiring anticoagulation (i.e. atrial fibrillation or cerebral infarct requiring anticoagulation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01345773

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Keun-Wook Lee, M.D. & Ph.D., Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01345773     History of Changes
Other Study ID Numbers: GC-VTE-01
Study First Received: April 29, 2011
Last Updated: November 16, 2011
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Stomach Neoplasms
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on August 20, 2014